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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-18
Device Problems Break (1069); Positioning Failure (1158); Retraction Problem (1536)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline that the pipeline was difficult to open and the pushwire was noted to be separated at the proximal marker after resistance occurred in the phenom catheter during retrieval. The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular posterior communicating artery aneurysm. The aneurysm max diameter was 4mm and the neck diameter was 4mm. Vessel tortuosity was normal. It was reported that the pipeline and all accessory device were prepared as indicated in the instructions for use (ifu). The phenom catheter was in place and the pipeline was delivered. The tail end of the stent was difficult to open but after repeated attempts, it did finally open. The phenom was pushed forward and the wire was recovered but the proximal marker was stuck at the phenom tip. After pulling back, the pushwire was disconnected at the proximal marker and the distal part of the proximal marker remained in the patient's body. Attempts were made to collect the marker with a solitaire ab (sab) without success so the sab was deployed to prevent migration of the detached marker and the procedure was complete. There were no associated patient symptoms.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12343696
MDR Text Key267309747
Report Number2029214-2021-01038
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-18
Device Catalogue NumberPED-400-18
Device Lot NumberB163278
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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